1. Choose your Affinity Group

* Equal Opportunity / Affirmative Action

We serve Equal Opportunity Employers and are an Equal Opportunity Employer. The Professional Diversity Network has separate professional networking sites for different affinities, and in selecting the groups you identify with, you will be joined with those networks.

Note: Providing this information is strictly voluntary - you will not be penalized or subjected to adverse treatment. If you choose not to provide this information, simply select "Choose not to identify."

2. Choose Method
X
Sign in with LinkedIn
Sign in with Facebook
OR

Tell us about yourself

Computer Systems Validation Specialist
at Alpha Consulting
New Brunswick, NJ

Computer Systems Validation Specialist
at Alpha Consulting
New Brunswick, NJ

Save or bookmark jobs as you go and access them anytime later with your account.

Contacts

Description

Job Description

COMPUTER SYSTEMS VALIDATION SPECIALIST
NEW BRUNSWICK, NJ


Required Skills:
  • 6+ years' experience.
  • Experience in producing software documentation and business requirement documentation (minimum 3 yrs.); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.
  • Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
  • Ability to create documents to an existing document standard.
  • Working knowledge of Documentum.
  • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
  • Able to develop all documentation required for a 21/11 validated project, including Validation Plans and Summaries.

Project Description:
  • Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes.
  • Follow SOPs and industry best practices.
  • Conduct training on good documentation and good testing practices.
  • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.
  • Review validation deliverables for projects which are contracted to third party suppliers.
  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.
  • Assist in planning, implementing, and documenting user acceptance testing.
  • Review computerized systems validation documents such as:
    • Requirements Specification
    • Design Specification
    • CSV Risk Assessment
    • Test Plans
    • Test Summary Reports
    • Data Migration Plan
    • Pre/Post Executed Test Scripts
    • Traceability Matrix
    • Release to Production Statements
  • Direct and review testing.
  • Provide guidance on quality issues that affect the integrity of the data or the system.
  • Prepare validation summary and test summary reports.
  • Obtain and respond to QA review.
  • Participate in establishing standard quality and validation practices.
  • Independently assess compliance practices and recommend corrective actions.
  • Approve validated computer system related change requests.
  • Monitor regulatory and inspection trends and advise the business on suitable action.


This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.com

ALPHA'S REQUIREMENT #18-01546
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Similar Jobs

See All »

Other Jobs at Alpha Consulting

See All »